Fezolinetant
DrugOral
Other names: ESN364, VEOZAH
NCT Number: NCT07602530
This study is for women in Canada who are in menopause. They have symptoms including hot flashes and night sweats (also known as vasomotor symptoms or VMS). Their own doctor has prescribed fezolinetant for hot flashes and night sweats, as part of routine health care in Canada.
In this study, women will be taking tablets of fezolinetant. This study is about recording information only. The women's own doctor decides on treatment, not the study sponsor (Astellas).
Women are taking fezolinetant every day for up to 52 weeks (1 year). The main aim is to learn if fezolinetant improves hot flashes and night sweats after 12 weeks. Other aims are to learn if fezolinetant improves hot flashes and night sweats throughout the study. This includes improved sleep and the women's wellbeing. Details are recorded on how satisfied the women are with fezolinetant and if they completed their treatment. This includes reasons for stopping treatment. Any safety issues are recorded. Details about other treatments taken before or with fezolinetant are also recorded.
Interested in participating?
Request InfoFemale
Observational
Site CA15002, Montreal, Canada
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Oral
Other names: ESN364, VEOZAH
Time frame: Week 12
The PGI-C VMS evaluates patient perceived change in hot flashes/night sweats from the initiation of treatment. Ratings range from (1) much better to (7) much worse. A response of "moderately better" or "much better" would be an improvement.
Time frame: Up to Week 24
The PGI-C VMS evaluates patient perceived change in hot flashes/night sweats from the initiation of treatment. Ratings range from (1) much better to (7) much worse. A response of "moderately better" or "much better" would be an improvement.
Time frame: Baseline, Week 4, 12, 24 and 52
The HFRDIS measures the impact of VMS on the participant's overall quality of life and specific activities: work, social activities, leisure activities, sleep, mood, concentration, relations with others, sexuality and enjoyment of life. Responses to each of the 10 items range from 0 (do not interfere) to 10 (completely interfere); higher numbers indicate more interference.
Time frame: Baseline, Week 4, 12, 24 and 52
The PROMIS SD SF 8b assesses self-reported sleep disturbance over the previous 7 days and includes perceptions of restless sleep; satisfaction with sleep; refreshing sleep; difficulties sleeping, getting to sleep or staying asleep; amount of sleep; and sleep quality. Responses to each of the 8 items range from 1 to 5, and the range of possible summed raw scores is 8 to 40. Higher scores on the PROMIS SD SF 8b indicate more of the concept measured (disturbed sleep).
Time frame: Baseline, Week 4, 12, 24 and 52
The PROMIS SD SF 8b assesses self-reported sleep disturbance over the previous 7 days and includes perceptions of restless sleep; satisfaction with sleep; refreshing sleep; difficulties sleeping, getting to sleep or staying asleep; amount of sleep; and sleep quality. T-scores are raw scores rescaled with score of 50 corresponding to the population average and standard deviation of 10.
Time frame: Baseline, Week 4, 12 and 24
PGI-C SD evaluates patient perceived change in sleep disturbance from the initiation of treatment. Ratings range from (1) much better to (7) much worse. A response of "moderately better" or "much better" would be an improvement.
Time frame: Baseline, Week 4, 12, 24 and 52
The PGI-S SD evaluates patient perceived severity of hot flashes/night sweats. Ratings range from (1) no problems to (4) severe problems.
Time frame: Baseline, Week 4, 12, 24 and 52
The PROMIS SRI SF 8a assesses sleep-related impairment over the past 7 days. It includes self-reported perceptions of waking alertness, sleepiness and function within the context of overall sleep-wake function. Responses to each of the 8 items range from 1 to 5, and the range of possible summed raw scores is 8 to 40. Higher scores are associated with more impaired sleep and range between 8 and 40.
Time frame: Baseline, Week 4, 12, 24 and 52
The Patient-reported Outcomes Measurement Information System Sleep-related Impairment - Short Form 8a (PROMIS SRI SF 8a) assesses sleep-related impairment over the past 7 days. It includes self-reported perceptions of waking alertness, sleepiness and function within the context of overall sleep-wake function. T-scores are raw scores rescaled with score of 50 corresponding to the population average and standard deviation of 10.
Time frame: Up to Week 24
Participants will complete 1 question ("Are you satisfied with your Veozah treatment?") in the TS-VAS to assess treatment satisfaction. Provisional response options range from 0% (no, not at all) to 100% (yes, completely). The participant's response is to indicate on the line by the distance from either end how satisfied they are.
Time frame: Up to Week 52
The TC-VAS is a VAS that asks participants to report the number of doses of fezolinetant they have actually taken from the number of doses planned as a percentage (% compliance) with a question. Provisional response options range from 0% (no, not at all) to 100% (yes, completely). The participant's response is to indicate on the line by the distance from either end how compliant they are.
Time frame: Day 1
The reason(s) for treatment initiation will be collected.
Time frame: Up to Week 52
The number of participants who discontinue fezolinetant.
Time frame: Day 1
Details of previous therapies for VMS will be recorded.
Time frame: Up to Week 52
Details of concomitant therapies will be recorded.
Time frame: Up to Week 56
An adverse event is any untoward medical occurrence in a participant administered a drug and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product whether or not considered related to the medicinal (investigational) product.
Time frame: Up to Week 56
An adverse event is considered "serious" if, in the view of either the medically qualified person or sponsor, it results in death, is life threatening, results in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, results in congenital anomaly, or birth defect, requires inpatient hospitalization or leads to prolongation of hospitalization, or a medically important event.
Time frame: Day 1
Demographics of interest will be recorded.
Contact information is provided by the study sponsor or research team.
Astellas Pharma Europe Ltd.
Industry
A Real-world Observational Study of Outcomes Among Canadian Women With Bothersome VMS Associated With Menopause Who Are Treated With Fezolinetant in a Real-life Setting According to Routine Healthcare Practice
Acronym: CANDLELIGHT
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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